Clinical Trial Search

Primary: Percentage of Patients With Negative HDV RNA by PCR — 0; 53.3; 26.7; 6.7 Percentage of participants — p=0.0022

Primary: Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs — 18 Participants

Primary: Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment — 1; 1; 1; 0…

Primary: Histological Response at 3 Years — 6 participants

Primary: Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) — 16.7; 32.0; 46.0; 12.0 percentage of…

Primary: Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy. — -0.13; -0.73; -1.54 log(IU/ml) — p=0.03

Primary: Percentage of Participants With Combined Response at Week 48 — 2.0; 44.9; 48.0 percentage of participants — p=<0.0001

Primary: Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy — 0; 0; 0 Participants

Primary: Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects…

Primary: Number of Participants With a Virological Response — 12; 24; 9; 27 Participants

Primary: Change in Interferon-stimulated-gene (ISG) Expression — -2.716; 1.670; -2.20; -1.597 log 2 fold change

Primary: Maintained Combined Response (Virological, Biochemical and Histological Response). — 15; 6; 7; 13 participants — p=0.0294

Primary: Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 — 6.045 Events per person-year

Primary: Number of Subjects With Adverse Events as Assessed by CTCAE v5.0 — 9; 13; 3; 16 Participants

Primary: Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in…

Primary: Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer — -1.62 log IU/mL

Primary: Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks — 26; 1; 80; 53 Participants…

Primary: Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population) — 52 participants

Primary: The Dynamic Change of HBV DNA — 3.15; 3.14 IU/mL

Primary: Change in HBsAg Levels From Baseline to 2 Years — -0.27 log IU/ml — p=<0.05

Primary: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter…

Primary: Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period — 11.8; 25.0; 20.0 percentage of participants — p=0.08

Primary: Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) — 13; 2 participants

Primary: Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment…

Primary: Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 — 4.1; 5.2 Percentage of participants — p=0.72

Primary: Percentage of Participants With HBeAg Seroconversion at Week 48 — 21; 23 Participants

Primary: Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) — 7 participants

Primary: Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 — 85; 403 participants

Primary: Change From Baseline in HDV Viral Load. — -2.14; -1.16 Change in HDV RNA log IU/mL

Primary: Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) — 59.13 percent change